US6996952B2 - Method for improving stability and effectivity of a drug-device combination product - Google Patents
Method for improving stability and effectivity of a drug-device combination product Download PDFInfo
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- US6996952B2 US6996952B2 US10/676,333 US67633303A US6996952B2 US 6996952 B2 US6996952 B2 US 6996952B2 US 67633303 A US67633303 A US 67633303A US 6996952 B2 US6996952 B2 US 6996952B2
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- 239000013069 drug device combination product Substances 0.000 title claims abstract description 7
- 238000000034 method Methods 0.000 title claims description 27
- 239000000047 product Substances 0.000 claims abstract description 42
- 238000007789 sealing Methods 0.000 claims abstract description 12
- 239000007789 gas Substances 0.000 claims description 67
- 230000001954 sterilising effect Effects 0.000 claims description 46
- 238000004659 sterilization and disinfection Methods 0.000 claims description 20
- 238000004806 packaging method and process Methods 0.000 claims description 14
- 239000000126 substance Substances 0.000 claims description 12
- 230000001028 anti-proliverative effect Effects 0.000 claims description 8
- 239000011261 inert gas Substances 0.000 claims description 7
- 230000003110 anti-inflammatory effect Effects 0.000 claims description 6
- 239000004599 antimicrobial Substances 0.000 claims description 6
- 229940000425 combination drug Drugs 0.000 claims 1
- 229940079593 drug Drugs 0.000 description 24
- 239000003814 drug Substances 0.000 description 24
- 239000000463 material Substances 0.000 description 11
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- 102400000068 Angiostatin Human genes 0.000 description 4
- 108010079709 Angiostatins Proteins 0.000 description 4
- AOJJSUZBOXZQNB-TZSSRYMLSA-N Doxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-TZSSRYMLSA-N 0.000 description 4
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- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 4
- 239000003242 anti bacterial agent Substances 0.000 description 4
- 229940088710 antibiotic agent Drugs 0.000 description 4
- FZCSTZYAHCUGEM-UHFFFAOYSA-N aspergillomarasmine B Natural products OC(=O)CNC(C(O)=O)CNC(C(O)=O)CC(O)=O FZCSTZYAHCUGEM-UHFFFAOYSA-N 0.000 description 4
- 239000000645 desinfectant Substances 0.000 description 4
- OSVXSBDYLRYLIG-UHFFFAOYSA-N dioxidochlorine(.) Chemical compound O=Cl=O OSVXSBDYLRYLIG-UHFFFAOYSA-N 0.000 description 4
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 4
- 239000005022 packaging material Substances 0.000 description 4
- 229920000642 polymer Polymers 0.000 description 4
- JQXXHWHPUNPDRT-WLSIYKJHSA-N rifampicin Chemical compound O([C@](C1=O)(C)O/C=C/[C@@H]([C@H]([C@@H](OC(C)=O)[C@H](C)[C@H](O)[C@H](C)[C@@H](O)[C@@H](C)\C=C\C=C(C)/C(=O)NC=2C(O)=C3C([O-])=C4C)C)OC)C4=C1C3=C(O)C=2\C=N\N1CC[NH+](C)CC1 JQXXHWHPUNPDRT-WLSIYKJHSA-N 0.000 description 4
- 229960001225 rifampicin Drugs 0.000 description 4
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 3
- 230000003647 oxidation Effects 0.000 description 3
- 238000007254 oxidation reaction Methods 0.000 description 3
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- UEJJHQNACJXSKW-UHFFFAOYSA-N 2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione Chemical compound O=C1C2=CC=CC=C2C(=O)N1C1CCC(=O)NC1=O UEJJHQNACJXSKW-UHFFFAOYSA-N 0.000 description 2
- AOJJSUZBOXZQNB-VTZDEGQISA-N 4'-epidoxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-VTZDEGQISA-N 0.000 description 2
- 108090000644 Angiozyme Proteins 0.000 description 2
- 239000004155 Chlorine dioxide Substances 0.000 description 2
- 229920001634 Copolyester Polymers 0.000 description 2
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 description 2
- 102400001047 Endostatin Human genes 0.000 description 2
- 108010079505 Endostatins Proteins 0.000 description 2
- HTIJFSOGRVMCQR-UHFFFAOYSA-N Epirubicin Natural products COc1cccc2C(=O)c3c(O)c4CC(O)(CC(OC5CC(N)C(=O)C(C)O5)c4c(O)c3C(=O)c12)C(=O)CO HTIJFSOGRVMCQR-UHFFFAOYSA-N 0.000 description 2
- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- CEAZRRDELHUEMR-URQXQFDESA-N Gentamicin Chemical compound O1[C@H](C(C)NC)CC[C@@H](N)[C@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](NC)[C@@](C)(O)CO2)O)[C@H](N)C[C@@H]1N CEAZRRDELHUEMR-URQXQFDESA-N 0.000 description 2
- 229930182566 Gentamicin Natural products 0.000 description 2
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 description 2
- CMWTZPSULFXXJA-UHFFFAOYSA-N Naproxen Natural products C1=C(C(C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-UHFFFAOYSA-N 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 2
- 229930012538 Paclitaxel Natural products 0.000 description 2
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- 239000004698 Polyethylene Substances 0.000 description 2
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- UIRKNQLZZXALBI-MSVGPLKSSA-N Squalamine Chemical compound C([C@@H]1C[C@H]2O)[C@@H](NCCCNCCCCN)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@H](C)CC[C@H](C(C)C)OS(O)(=O)=O)[C@@]2(C)CC1 UIRKNQLZZXALBI-MSVGPLKSSA-N 0.000 description 2
- UIRKNQLZZXALBI-UHFFFAOYSA-N Squalamine Natural products OC1CC2CC(NCCCNCCCCN)CCC2(C)C2C1C1CCC(C(C)CCC(C(C)C)OS(O)(=O)=O)C1(C)CC2 UIRKNQLZZXALBI-UHFFFAOYSA-N 0.000 description 2
- 239000004098 Tetracycline Substances 0.000 description 2
- 239000004775 Tyvek Substances 0.000 description 2
- 229920000690 Tyvek Polymers 0.000 description 2
- 229940121369 angiogenesis inhibitor Drugs 0.000 description 2
- 239000004037 angiogenesis inhibitor Substances 0.000 description 2
- 238000002399 angioplasty Methods 0.000 description 2
- 239000002260 anti-inflammatory agent Substances 0.000 description 2
- 229940121363 anti-inflammatory agent Drugs 0.000 description 2
- 230000002421 anti-septic effect Effects 0.000 description 2
- 229940064004 antiseptic throat preparations Drugs 0.000 description 2
- 210000001367 artery Anatomy 0.000 description 2
- 229960004099 azithromycin Drugs 0.000 description 2
- MQTOSJVFKKJCRP-BICOPXKESA-N azithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)N(C)C[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 MQTOSJVFKKJCRP-BICOPXKESA-N 0.000 description 2
- 230000004888 barrier function Effects 0.000 description 2
- 229960000397 bevacizumab Drugs 0.000 description 2
- 230000036770 blood supply Effects 0.000 description 2
- 201000011510 cancer Diseases 0.000 description 2
- 229940044683 chemotherapy drug Drugs 0.000 description 2
- 235000019398 chlorine dioxide Nutrition 0.000 description 2
- 229920001577 copolymer Polymers 0.000 description 2
- 229960004397 cyclophosphamide Drugs 0.000 description 2
- 229960004679 doxorubicin Drugs 0.000 description 2
- 229960002549 enoxacin Drugs 0.000 description 2
- IDYZIJYBMGIQMJ-UHFFFAOYSA-N enoxacin Chemical compound N1=C2N(CC)C=C(C(O)=O)C(=O)C2=CC(F)=C1N1CCNCC1 IDYZIJYBMGIQMJ-UHFFFAOYSA-N 0.000 description 2
- 229960001904 epirubicin Drugs 0.000 description 2
- 239000004715 ethylene vinyl alcohol Substances 0.000 description 2
- 239000005021 flexible packaging material Substances 0.000 description 2
- 239000011888 foil Substances 0.000 description 2
- 229960002518 gentamicin Drugs 0.000 description 2
- 229960001680 ibuprofen Drugs 0.000 description 2
- 238000007654 immersion Methods 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- DKYWVDODHFEZIM-UHFFFAOYSA-N ketoprofen Chemical compound OC(=O)C(C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-UHFFFAOYSA-N 0.000 description 2
- 229960000991 ketoprofen Drugs 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000003120 macrolide antibiotic agent Substances 0.000 description 2
- 229940041033 macrolides Drugs 0.000 description 2
- WSFSSNUMVMOOMR-NJFSPNSNSA-N methanone Chemical compound O=[14CH2] WSFSSNUMVMOOMR-NJFSPNSNSA-N 0.000 description 2
- 229960001156 mitoxantrone Drugs 0.000 description 2
- KKZJGLLVHKMTCM-UHFFFAOYSA-N mitoxantrone Chemical compound O=C1C2=C(O)C=CC(O)=C2C(=O)C2=C1C(NCCNCCO)=CC=C2NCCNCCO KKZJGLLVHKMTCM-UHFFFAOYSA-N 0.000 description 2
- 229940072709 motrin Drugs 0.000 description 2
- 229960002009 naproxen Drugs 0.000 description 2
- CMWTZPSULFXXJA-VIFPVBQESA-N naproxen Chemical compound C1=C([C@H](C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-VIFPVBQESA-N 0.000 description 2
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- 229960001592 paclitaxel Drugs 0.000 description 2
- 150000002960 penicillins Chemical class 0.000 description 2
- 239000012466 permeate Substances 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 229920002223 polystyrene Polymers 0.000 description 2
- 239000005033 polyvinylidene chloride Substances 0.000 description 2
- 208000037803 restenosis Diseases 0.000 description 2
- 229950001248 squalamine Drugs 0.000 description 2
- 239000003206 sterilizing agent Substances 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 description 2
- 235000019364 tetracycline Nutrition 0.000 description 2
- 150000003522 tetracyclines Chemical class 0.000 description 2
- 229940040944 tetracyclines Drugs 0.000 description 2
- 229960003433 thalidomide Drugs 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 239000012472 biological sample Substances 0.000 description 1
- 229960002227 clindamycin Drugs 0.000 description 1
- KDLRVYVGXIQJDK-AWPVFWJPSA-N clindamycin Chemical compound CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@H](C)Cl)[C@@H]1[C@H](O)[C@H](O)[C@@H](O)[C@@H](SC)O1 KDLRVYVGXIQJDK-AWPVFWJPSA-N 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
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- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 229940127554 medical product Drugs 0.000 description 1
- GPXLMGHLHQJAGZ-JTDSTZFVSA-N nafcillin Chemical compound C1=CC=CC2=C(C(=O)N[C@@H]3C(N4[C@H](C(C)(C)S[C@@H]43)C(O)=O)=O)C(OCC)=CC=C21 GPXLMGHLHQJAGZ-JTDSTZFVSA-N 0.000 description 1
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- 238000012856 packing Methods 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/206—Ethylene oxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/14—Plasma, i.e. ionised gases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D33/00—Details of, or accessories for, sacks or bags
- B65D33/01—Ventilation or drainage of bags
Definitions
- This invention relates to a package for a drug-device combination product having an outer package including a first gas impermeable sheet, a second gas impermeable sheet and a gas permeable header.
- Packaging a product in an inner package and then packing the inner package in an outer package is common in the packaging arts.
- Vacuum packaging, packaging with an inert gas and multiple methods of sterilizing medical products are known in the medical device packaging art.
- drug-device combination products offer a new and unique problem in the packaging and sterilizing of the product, while refraining from altering the chemical structure of the drug incorporated in the device.
- Numerous inventions relate to the use of radiation to sterilize products for medical use, for example, U.S. Pat. No. 5,577,368 to Hamilton et al. (“Hamilton”) and U.S. Pat. No. 6,174,934 to Sun et al. (“Sun”). Both Hamilton and Sun first remove the oxygen/atmosphere from the packaging prior to radiation sterilizing medical implants made of polymeric material. Hamilton's and Sun's goal is to reduce the wear resistance of the polymeric implant and, radiation typically alters the chemical structures of incorporated drugs.
- U.S. Pat. No. 4,941,308 to Grabenkort et al. discloses sterilizing the interior of the package before placing the product in the inner package, sterilizing the product in the inner package, and then placing the inner package in the outer package. Additionally, Grabenkort et al. uses ethylene oxide gas (EtO) for the sterilization.
- EtO ethylene oxide gas
- a package for a drug-device combination product includes an outer package, including a first gas impermeable sheet and a second gas impermeable sheet hermetically sealed on three sides.
- the impermeable sheet material should be flexible and can be selected from among many types of high barrier, flexible packaging materials that are commonly used to enclose medical devices.
- the impermeable sheet material is a multilayered, heat seal peelable packaging material that includes one or more foil layers, various polymer layers and a heat seal coating. Examples of suitable materials are those that include the following layers: polyester film-low density polyethylene-foil-ionomer-heat seal coating.
- Packaging materials having the following layers can also be used: polyester-low density polyethylene-foil-EAA-linear low density polyethylene-heat seal coating; and polyester-Surlyn-nylon-Surlyn-foil-EAA-linear low density polyethylene-heat seal coating.
- PVDC polyvinylidene chloride
- EVOH ethylene vinyl alcohol copolymer
- Nylons, acrylonitrile methacrylate copolymer (AN-MA), and other specialty polymers such as certain copolyesters may potentially be used.
- a gas permeable header is attached to an unsealed side of the first gas impermeable sheet and sealed to the second gas impermeable sheet on two sides.
- the first and second gas impermeable sheets and the gas permeable header form an interior and an opening that communicates with the interior to form three sealed sides of the outer package.
- a gas permeable inner package is sized to fit the device and disposed within the outer package and preferable disposed only between the first and second gas impermeable sheets.
- the gas permeable material for both the header and/or the inner package can be Tyvek® or any other durable gas permeable material such as polyethylene, polystyrene or polypropylene.
- the gas permeable inner package can be a blister tray, a pouch, or any other gas permeable container designed to hold a product to be sterilized.
- the product can be incorporated with drugs that are antimicrobial agents, antiangiogenesis, antiproliferatives, and anti-inflammatorys. Incorporating the drug into the product can include, but is not limited to, impregnating, coating and sandwiching the drug between layers of the device.
- the antimicrobial agent can be selected from the group comprising antibiotics, antiseptics, and disinfectants.
- the antibiotics can be selected from a group comprising tetracyclines (i.e. minoclcine), penicillins, (i.e. nafcillin), macrolides (i.e. erythromycin), rifampin, gentamicin, vancomycinclindamycin, azithromycin, enoxacin, and combinations thereof.
- tetracyclines i.e. minoclcine
- penicillins i.e. nafcillin
- macrolides i.e. erythromycin
- rifampin gentamicin
- vancomycinclindamycin vancomycinclindamycin
- azithromycin enoxacin
- enoxacin enoxacin
- Antiangiogenesis drugs deprive the cancer cells of their blood supply.
- Antiangiogenesis can be selected from the group including angiostatin, thalidomide (ThalomidTM), CC-5013 (RevimidTM), bevacizumab (AvastinTM), squalamine, endostatin, angiostatin, and angiozyme.
- Other antiangiogenesis drugs can include drugs derived from chemotherapy drugs, for example, paclitaxel (TaxolTM), doxorubicin (AdriamycinTM), epirubicin, mitoxantrone, and cyclophosphamide.
- Antiproliferative drugs can prevent restenosis (a re-narrowing or blockage of an artery at the same site where treatment, such as an angioplasty or stent procedure, has already taken place) of the implanted device.
- antiproliferatives are SirolimusTM and PaclitaxelTM.
- anti-inflammatories including non-steroidal anti-inflammatory drugs (NSAID's), are ibuprofen, ketoprofen, motrin, and naproxen.
- the inner package is placed within the outer package and a top end of the header is sealed to the second sheet.
- the sterilizing compound is then introduced into the interior of the outer package through the header. Since the inner package is also permeable, the sterilizing compound can permeate through the inner package and sterilize the product.
- the sterilizing compound can be steam, ethylene oxide gas (EtO), gas plasma/radio frequency-peroxide (e.g. SterradTM), chemical vapor (e.g alcohol, formaldehyde, etc), and cold sterilization using liquid chemical sterilants/disinfectants that require immersion (e.g. glutaraldehyde and chlorine dioxide).
- EtO ethylene oxide gas
- gas plasma/radio frequency-peroxide e.g. SterradTM
- chemical vapor e.g alcohol, formaldehyde, etc
- cold sterilization using liquid chemical sterilants/disinfectants that require immersion e.g. glutaraldehyde and chlorine dioxide.
- the invention allows for any sterilization process that utilizes a sterilizing agent that can only pass through a permeable layer.
- the atmosphere can be evacuated from the interior to ‘vacuum seal’ the product, as well as retard further oxidation.
- the outer package is then sealed by sealing the first gas impermeable sheet to the second gas impermeable sheet at a seal point below the point where the header attaches to the first sheet.
- the outer package is now a gas impermeable package.
- the header can either be removed or folded over to complete the packaging.
- a key feature of the sterilizing step includes using any sterilizing process that maintains a chemical structure of the drug as well as prevents oxidation of the drug, and still sterilizes the product for medical use.
- FIG. 1 is an exploded perspective view of the outer package of the present invention
- FIG. 2 is a perspective view of the outer package of the present invention
- FIG. 2A is a cross-sectional view along line 2 A— 2 A of FIG. 2 ;
- FIG. 3 is a perspective view of the of the assembled outer package prior to the insertion of the inner package
- FIG. 3A is a cross-sectional view along line 3 A— 3 A of FIG. 3 ;
- FIG. 4 a perspective view of the of the inner package and outer package during sterilization
- FIG. 4A is a cross-sectional view along line 4 A— 4 A of FIG. 4 ;
- FIG. 5 is a perspective view of the inner package and outer package during evacuation
- FIG. 5A is a cross-sectional view along line 5 A— 5 A of FIG. 5 ;
- FIG. 6 is a perspective view of the inner package and outer package after evacuation
- FIG. 6A is a cross-sectional view along line 6 A— 6 A of FIG. 6 ;
- FIG. 7 is a perspective view of the final packaging.
- FIG. 8 is a flow chart outlining the method of the present invention.
- Package 100 includes an outer package 102 including a first gas impermeable sheet 104 and a second gas impermeable sheet 106 hermetically sealed on three sides 112 ( FIG. 3 ).
- a gas permeable header 108 is attached at an attachment point 109 located on an unsealed side 110 of first gas impermeable sheet 104 and sealed to second gas impermeable sheet 106 on two sides.
- First and second gas impermeable sheets 104 , 106 and gas permeable header 108 form an interior 114 with an opening 116 communicating with interior 114 .
- the impermeable sheet material should be flexible and can be selected from among many types of high barrier, flexible packaging materials that are commonly used to enclose medical devices.
- the impermeable sheet material is a multilayered, heat seal peelable packaging material that includes one or more foil layers, various polymer layers and a heat seal coating.
- suitable materials are those that include the following layers: polyester film-low density polyethylene-foil-ionomer-heat seal coating.
- Packaging materials having the following layers can also be used: polyester-low density polyethylene-foil-EAA-linear low density polyethylene-heat seal coating; and polyester-Surlyn-nylon-Surlyn-foil-EAA-linear low density polyethylene-heat seal coating.
- PVDC polyvinylidene chloride
- EVOH ethylene vinyl alcohol copolymer
- Nylons, acrylonitrile methacrylate copolymer (AN-MA), and other specialty polymers such as certain copolyesters may potentially be used.
- a gas permeable inner package 118 is disposed within outer package 102 . Additionally, gas permeable inner package 118 is preferably disposed only between first and second gas impermeable sheets 104 , 106 .
- the gas permeable material for both the header and/or the inner package can be Tyvek® or any other durable gas permeable material such as polyethylene, polystyrene or polypropylene.
- Gas permeable inner package 118 can be a blister tray, a pouch, or any other gas permeable container designed to hold a product 120 to be sterilized.
- FIG. 4A illustrates product 120 which, in an embodiment, can be incorporated with a drug (not illustrated) and gas permeable inner package 118 is sized to contain product 120 and be placed only between gas impermeable section of first sheet and second sheet 104 , 106 .
- the drugs that the product can be incorporated with are antimicrobial agents, antiangiogenesis, antiproliferatives, and anti-inflammatorys. Incorporating the drug into the product can include, but is not limited to, impregnating, coating and sandwiching the drug between layers of product 120 .
- the antimicrobial agent can be selected from the group comprising antibiotics, antiseptics, and disinfectants.
- the antibiotics can be selected from a group comprising tetracyclines (i.e. MinoclcineTM), penicillins, (i.e. NafcillinTM), macrolides (i.e. ErythromycinTM), rifampin, gentamicin, vancomycinclindamycin, azithromycin, enoxacin, and combinations thereof.
- a preferred product 120 is incorporated with RifampicinTM or ClindamycinTM.
- Antiangiogenesis drugs deprive the cancer cells of their blood supply.
- Antiangiogenesis can be selected from the group including angiostatin, thalidomide (ThalomidTM), CC-5013 (RevimidTM), bevacizumab (AvastinTM), squalamine, endostatin, angiostatin, and angiozyme.
- Other antiangiogenesis drugs can include drugs derived from chemotherapy drugs, for example, paclitaxel (TaxolTM), doxorubicin (AdriamycinTM), epirubicin, mitoxantrone, and cyclophosphamide.
- Antiproliferative drugs can prevent restenosis (a re-narrowing or blockage of an artery at the same site where treatment, such as an angioplasty or a stent procedure, has already taken place) of product 120 .
- antiproliferatives are SirolimusTM and PaclitaxelTM.
- anti-inflammatories including non-steroidal anti-inflammatory drugs (NSAID's), are ibuprofen, ketoprofen, motrin, and naproxen.
- FIGS. 3 through 4A further illustrate that once product 120 is sealed within inner package 118 , inner package 118 is placed within outer package 102 . A top end 122 of header 108 is sealed to second sheet 106 . A sterilizing compound 124 is then introduced into interior 114 through header 108 . Sterilizing compound 124 then permeates through inner package 118 and sterilizes product 120 .
- Sterilizing compound 124 can be steam, ethylene oxide gas (EtO), gas plasma/radio frequency-peroxide (e.g. SterradTM), chemical vapor (e.g alcohol, formaldehyde, etc), and cold sterilization using liquid chemical sterilants/disinfectants that require immersion (e.g. glutaraldehyde and chlorine dioxide).
- EtO ethylene oxide gas
- gas plasma/radio frequency-peroxide e.g. SterradTM
- chemical vapor e.g alcohol, formaldehyde, etc
- atmosphere 126 can be evacuated from interior 114 to ‘vacuum seal’ product 120 .
- Outer package 102 is then sealed by sealing first gas impermeable sheet 104 to second gas impermeable sheet 106 at a seal point 128 below attachment point 109 of header 108 to first sheet 104 .
- Outer package 102 is now a gas impermeable package.
- header 108 can either be removed or folded over to complete the packaging ( FIG. 7 ).
- FIG. 8 illustrates a method of packaging a drug-device combination product 120 such as, for example, but not limited to a drug incorporated catheter (e.g. BactisealTM) and a drug-eluting stent (e.g. CypherTM).
- the steps include placing product 120 inside gas permeable inner package 118 (step 202 ), sealing inner package 118 , and placing inner package 118 inside outer package 102 (step 204 ).
- Outer package 102 is formed as described above.
- Further steps include sealing the top end 122 of header 108 to second sheet 106 to seal inner package 118 in outer package 102 (step 204 ).
- step 206 product 120 is sterilized with sterilizing compound 126 (step 206 ) and the first sheet 104 is sealed to second sheet 106 to seal inner package 118 in a gas impermeable outer package (step 210 ).
- An embodiment includes, after the sterilizing step ( 206 ), removing atmosphere 126 from inside outer package 102 (step 208 ).
- step 212 another step includes removing the gas permeable header 108 (step 212 ), or as an alternative header 108 can be folded under outer package 102 .
- An embodiment includes, replacing atmosphere 126 with an inert gas (not illustrated) prior to removing the atmosphere 128 (step 208 ).
- Another embodiment includes, after removing the atmosphere (step 208 ), filling the outer package 102 with an inert gas (not illustrated).
- a key feature of the sterilizing step includes using steam, EtO, gas plasma/radio frequency-peroxide, chemical vapor, cold sterilization or any sterilizing process that maintains the chemical structure of the incorporated drug, prevents oxidation of the incorporated drug and also maintains the desired mechanical properties (rigidity, elasticity, etc.) of the device, while still sterilizing the product for medical use.
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Priority Applications (11)
Application Number | Priority Date | Filing Date | Title |
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US10/676,333 US6996952B2 (en) | 2003-09-30 | 2003-09-30 | Method for improving stability and effectivity of a drug-device combination product |
ES04256013T ES2316938T3 (es) | 2003-09-30 | 2004-09-29 | Un metodo y aparato para envasar ena combinacion de un farmaco y un dispositivo. |
JP2004284646A JP4610986B2 (ja) | 2003-09-30 | 2004-09-29 | 薬剤・装置複合製品用パッケージおよび包装方法 |
EP04256013A EP1520795B1 (en) | 2003-09-30 | 2004-09-29 | A method and apparatus for packaging a drug-device combination product |
AU2004216618A AU2004216618B2 (en) | 2003-09-30 | 2004-09-29 | Method and apparatus for packaging a drug-device combination product |
DE602004018244T DE602004018244D1 (de) | 2003-09-30 | 2004-09-29 | Verfahren und Vorrichtung zum Verpacken einer Kombination eines Medikaments und einer Vorrichtung |
AT04256013T ATE416987T1 (de) | 2003-09-30 | 2004-09-29 | Verfahren und vorrichtung zum verpacken einer kombination eines medikaments und einer vorrichtung |
CA002483219A CA2483219A1 (en) | 2003-09-30 | 2004-09-30 | Method for improving stability and effectivity of a drug device combination product |
BRPI0405163A BRPI0405163B1 (pt) | 2003-09-30 | 2004-09-30 | embalagem para combinação de produto droga-dispositivo e método de embalar uma combinação de produto droga-dispositivo |
CO04097769A CO5580147A1 (es) | 2003-09-30 | 2004-09-30 | Metodo y aparato para empacar un producto de combinacion de un medicamento en un dispositivo |
US11/174,115 US7040485B2 (en) | 2003-09-30 | 2005-07-01 | Method and apparatus for packaging a drug-device combination product |
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US10/676,333 US6996952B2 (en) | 2003-09-30 | 2003-09-30 | Method for improving stability and effectivity of a drug-device combination product |
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Also Published As
Publication number | Publication date |
---|---|
US20050067312A1 (en) | 2005-03-31 |
BRPI0405163A (pt) | 2005-05-24 |
US20050241981A1 (en) | 2005-11-03 |
EP1520795B1 (en) | 2008-12-10 |
DE602004018244D1 (de) | 2009-01-22 |
JP2005132491A (ja) | 2005-05-26 |
AU2004216618A1 (en) | 2005-04-14 |
CA2483219A1 (en) | 2005-03-30 |
BRPI0405163B1 (pt) | 2016-09-06 |
ATE416987T1 (de) | 2008-12-15 |
US7040485B2 (en) | 2006-05-09 |
CO5580147A1 (es) | 2005-11-30 |
JP4610986B2 (ja) | 2011-01-12 |
AU2004216618B2 (en) | 2010-12-02 |
ES2316938T3 (es) | 2009-04-16 |
EP1520795A1 (en) | 2005-04-06 |
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